Medicare Dental Benefit Act of 2023

General monitoring of legislative and administrative action related to health care policy; including the OTC Monograph Drug User Fee Program (OMUFA). General monitoring of legislative and administrative action related to womens health issues; General monitoring of legislative and administrative action related to over-the-counter consumer healthcare products; General monitoring of legislative and administrative action related to dietary supplements, multivitamin, and hunger issues; General monitoring of legislative and administrative action related to FDA monograph reform and user fees; General monitoring of legislative and administrative action related to the switch of prescription medications to over-the-counter medications; Review of coverage for medically necessary services in Medicare and Medicare Advantage General review and monitoring of processes impacting over-the-counter switches, including Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU) rulemaking process; Legislative and administrative action related to pseudoephedrine regulation; General monitoring of issues related to the reauthorization of "Pandemic and All-Hazards Preparedness Act" PAHPA; Review of legislation impacting the Dietary Supplement Health and Education Act of 1994, in particular, provisions related to Mandatory Product Listing (MPL); H.R. 831 Medicare Medically Necessary Dental Care Act of 2023; H.R. 994/S. 403 Oral Health Literacy Awareness Act; S.842 - Medicare and Medicaid Dental, Vision, and Hearing Benefit Act of 2023; H.R. 6284 Improving Measurements for Loneliness and Isolation Act; H.R. 4150/S.1954 Improving Whole Health for Veterans with Chronic Conditions Act; H.R. 4146 /S.2012 Medicare Dental Benefit Act of 2023 S.3393 SUPPORT for Patients and Communities Reauthorization Act, specifically provisions related to non-opioid alternatives to acute and chronic pain management; General review of legislation and amendments focusing on non-addictive, non-opioid pain management medications, with a focus on over-the-counter (OTC) options; and Monitoring of regulatory proposals impacting inclusion of routine non-pediatric dental services as Essential Health Benefits (EHBs)

Client expense: $240,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

MMM [House, Senate, HHS, CMS, FDA, Administration on Aging, EOP, DOC] Medicare Observation Stays. The Improving Access to Medicare Coverage Act of 2023 (H.R. 5138 and S. 4137): Proposals to count time spent in observation status toward the three-day prior inpatient stay required under Medicare for coverage of a subsequent stay in a skilled nursing facility. Medicare Drug Prices (No bill): Proposal to have the Biden Administration lower the price of the prostate cancer drug Xtandi through executive action by using so-called march-in rights under the Bayh-Dole Act; to amend the Federal Food, Drug, and Cosmetic Act to grant eligible researchers access to drugs or biologic products for research purposes at a price no higher than the cost to the manufacturer; to block so-called Dispense-As-Written campaigns where drug manufacturers incentivize health care providers to specify a brand drug on a prescription to block generic substitution at the pharmacy. Medicare Drug Costs. The Pharmaceutical Research Transparency Act of 2023 (S. 1476 and H.R. 3160): Proposal to amend the Public Health Service Act and the Security Exchange Act to require pharmaceutical manufacturers to report their costs related to clinical trials and research and development. Medicare Drug Savings. The Seniors Securing Access to Vital and Essential Prescription Drugs Act (H.R. 2893): Proposals to discount the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost sharing subsidies under Part D of the Medicare program. (No bills): Proposals to eliminate the Medicare Part D low-income subsidy programs asset test and raise the income eligibility levels to 200 percent of the federal poverty level. Medicare Prescription Drugs. Drug Costs. Inflation Reduction Act (Public Law No: 117-169): Proposal to allow Medicare to negotiate prices with drug makers, cap prices at inflation in Part B and D, cap beneficiary out-of-pocket costs in Part D, eliminate cost-sharing for vaccines, eliminate cost-sharing in the catastrophic phase of Part D, and to raise the income threshold for the Low-Income Subsidy program offering assistance in paying for drugs. Medicare Prescription Drugs. The Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 (H.R. 3093): Proposals to require companies that receive federal funding for research (or a license of the rights to a patent or regulatory test data) for a biomedical product or service to agree to set reasonable prices for the resulting biomedical product or service and authorize to determine a reasonable price based on a formula that ensures the U.S. price for the product or service is not more than the median price for the product or service in Canada and six other reference countries. Medicare Prescription Drugs. (No bill): A regulatory proposal encouraging the Secretaries of the Departments of Health and Human Services (HHS) and Commerce to exercise march in rights that would aim to better control the pricing of prescription drugs. Medicare Prescription Drugs. (No bill): An HHS regulatory proposal to ensure robust negotiation rules and processes that aim to curtail the cost of certain prescription drugs, as authorized by the Inflation Reduction Act (Public Law No: 117-169). Medicare and Medicaid Prescription Drugs. (No bill): Joined comments with 19 other organizations urging HHS to use its existing authority to license competition in order to lower consumer and taxpayer costs for semaglutide drugs treating diabetes and weight management (e.g., Ozempic and Wegovy). Medicare Prescription Drugs. The PACE Part D Choice Act (H.R. 3549 and S. 1703): Proposal to increase the affordability of the Program of All-Inclusive Care for the Elderly (PACE) for Medicare beneficiaries by lowering the cost of Part D premiums substantially for Medicare-only enrollees, thus opening up the PACE program to this population. Medicare Low-Income Subsidy (LIS) Program. (No bill): Proposal to increase funding for LIS outreach and enrollment, so that low-income beneficiaries can more readily access needed medications at prices they can afford. Medicare Reform. The Assuring Medicares Promise Act (H.R. 34) and The Medicare and Social Security Fair Share Act (S. 1174 and H.R. 4535): Proposals to close the loophole for wealthy individuals who bypass paying net investment income tax (NIIT) and directing the revenue to the Hospital Insurance Trust Fund, which pays for Medicare Part A that covers inpatient care in hospitals, and to the Social Security Trust Funds. Medicare Trustees Report (No bill). Review of the findings on economic, legislative and other developments affecting the actuarial soundness of the Medicare Part A (Hospital Insurance) Trust Fund and the Trust Funds for Parts B and D coverage. Medicare Dental Coverage. The Medicare Dental Benefit Act (S. 2012 and H.R. 4146): Proposal to add a dental benefit to Medicare. Medicare Hearing Coverage. The Help Extend Auditory Relief Act of 2024 (H.R. 8064): Proposal to expand Medicare coverage to include hearing examinations and diagnoses, fittings and hearing aids. Medicare call center (No bill): Proposal to address the poor working conditions of the call center workers employed by Maximus, a federal contractor with the Department of Health and Humans Services/Center for Medicare and Medicaid Services) HHS/CMS. Public Health Emergency (No bill): Proposals to ensure the transition out of the public health emergency doesnt create enrollment or coverage gaps for Medicare eligible individuals. Medicare Advantage (MA). (No bill): Proposals to create transparency around Medicare Advantage plans using prior authorization and supplemental benefits that are not offered under traditional Medicare. Medicare Advantage. (No bill): Proposals to apply a higher coding adjustment factor to fully account for intensive upcoding by MA plans and to exclude certain information for MA risk adjustment scores and payments; to use two years of traditional Medicare and MA diagnostic data for calculating MA risk-adjusted payments; and to promulgate more fundamental changes to the Hierarchical Condition Category (HCC) risk adjustment model. Medicare Privatization (No bill): Proposals to create reimbursement policies in traditional Medicare that mimic those used by private health insurance plans. Medicaid Home and Community-Based Services. The HCBS Access Act (H.R. 1493 and S. 762): Proposals to make home and community-based services (HCBS) a mandatory benefit within Medicaid, and to ensure eligible older adults and people with disabilities have the option to choose between home care and institutional care. Caregiving. The Alleviating Barriers to Caregiving Act (H.R. 8018 and S. 3109): Proposal to require the Secretaries of HHS and SSA to review and streamline enrollment in coverage and benefits for family caregivers in Medicare, Medicaid, CHIP and Social Security. Medicare and Medicaid Nursing Homes. The Nursing Home Disclosure Act (H.R. 177): Proposal to direct HHS to establish a national registry of medical directors. Medicare, Medicaid Nursing Homes. The Protecting Americas Seniors Access to Care Act (H.R. 7513 and S. 3410): Proposal to prohibit the HHS Secretary from promulgating national staffing standards in nursing homes. Medicare, Medicaid Nursing Homes. (H.J. Res. 139 and S.J. Res. 91): Proposal to use the Congressional Review Act to disapprove the HHS Secretarys final rule promulgating national staffing standards in nursing homes Medicare, Medicaid Nursing Homes. The Building Americas Health Care Workforce Act (H.R. 9067): Proposal to allow time spent working in a nursing home (prior to any formal training, and permitted during the COVID-19 pandemic) to count toward a 75-hour minimum federal training standard that is required for certified nursing assistants. Medicare, Medicaid Nursing Homes. The Ensuring Seniors Access to Quality Care Act (H.R. 3227): Proposal to repeal regulations that prohibit certified nursing assistant training and competency evaluation programs in skilled nursing facilities that have a record of health and safety deficiencies and have incurred penalties (e.g., civil monetary penalties for substandard quality of care). Medicare, Medicaid Nursing Homes, Assisted Living and Other Long Term Care Services and Supports (LTSS) Settings. The Long-Term Care Workforce Support Act (H.R. 7994 and S. 4120): Proposals to increase the number of direct care professionals, including in rural communities; pathways to enter and be supported in the workforce for women, people of color, and people with disabilities; and to improve compensation for direct care professionals to reduce vacancies and turnover. Medicare and Medicaid Nursing Home Ownership. (No bill): A final HHS regulation for comprehensive ownership disclosure in the nursing home sector issued on November 17th, 2023. Rule calls for strengthened cost reporting requirements, together with ongoing national analyses and monitoring of the performance of the nursing home sector that uses ownership, staffing, cost report data and inspection data. Medicare and Medicaid Nursing Home Staffing. (No bill): Final regulations establishing national staffing standards in nursing homes that would safeguard the health and safety of all elderly and disabled residents. Medicaid Long-Term Services and Supports (LTSS). (No bill): Proposals to request that CMS collect standardized LTSS expenditure data annually from every state and across all LTSS programs and for disaggregation of expenditure data by the delivery system and demographic characteristics in order to identify disparities in access and use of LTSS and help states and CMS deploy targeted strategies to meet the needs of older adults and people with disabilities. Oversight of Health Care Industry Owned by Private Equity Firms. (No bill): Joined with other organizations in submitting comments (April 2024) to HHS, the Federal Trade Commission and the Department of Justice urging sustained, stepped up and rigorous oversight be extended to health care industry transactions that are financed by private equity company companies and other types of private investors. Medicaid Eligibility and Beneficiary Assets. Medicaid Estate Recovery Act (H.R. 7573): Proposals to provide financial protection to the families of Medicaid beneficiaries, including ending Medicaid estate claims and Medicaid liens, except in cases when benefits had been incorrectly paid, as determined by a court.

Medicare Dental Benefit Act (H.R. 4146, S. 2012), Medicare Dental, Vision and Hearing Benefit Act (H.R. 33), Medicare Heart Aid Act (H.R. 244), Beneficiary Enrollment Notification and Eligibility Act 2.0 (S. 1687), Preserve Access to Affordable Generics and Biosimilars Act (S. 142).

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Sustaining Outpatient Services Act (H.R. 955/S. 1849) Regulations from the Executive in Need of Scrutiny (REINS) Act of 2023 (HR 277/S 184) Increasing Access to Quality Cardiac Rehabilitative Care Act (HR 2583/S. 3481) Black Maternal Health Momnibus Act (S. 1606/HR 3305) Medicare Dental Benefit Act (HR 4146/S. 2012) Accelerating Kids Access to Care Act (H.R. 4758/S. 2372) Amputation Reduction and Compassion Act (H.R. 4261) CONNECT for Health Act (S. 2016, H.R. 4189) Kickstarting Innovative Demonstrations Supporting (KIDS) Health Act of 2023 (HR 3805/ S. 1769) Expanding Remote Monitoring Access Act (H.R.5394) Physical Activity Omnibus Legislation (No Bill Number) Preventing Maternal Deaths Reauthorization Act of 2023 (H.R. 3838/S. 2415) PREEMIE Reauthorization Act of 2023 (H.R. 3226/S. 1573) Sustainable Cardiopulmonary Rehabilitation Services in the Home Act (S. 3021) Supporting Innovation for Seniors Act (H.R. 5388) Supporting Patient Education And Knowledge (SPEAK) Act of 2023 (H.R. 6033) Wearable Equipment

Client expense: $200,000 · Firm income: Not reported

General monitoring of legislative and administrative action related to health care policy; General monitoring of legislative and administrative action related to womens health issues; General monitoring of legislative and administrative action related to over-the-counter consumer healthcare products; General monitoring of legislative and administrative action related to dietary supplements, multivitamin, and hunger issues; General monitoring of legislative and administrative action related to FDA monograph reform and user fees; General monitoring of legislative and administrative action related to the switch of prescription medications to over-the-counter medications; Review of issues related to Prescription Drug User Fee Act Reauthorization (PDUFA); Review of coverage for medically necessary services in Medicare and Medicare Advantage, including dental coverage, to address underlying conditions in advance of major surgery; General review and monitoring of processes impacting over-the-counter switches, including Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU) rulemaking process Monitor and engage on legislative and administrative action related to phenylephrine and pseudoephedrine regulation. General monitoring of issues related to the reauthorization of "Pandemic and All-Hazards Preparedness Act" PAHPA Review of legislation impacting the Dietary Supplement Health and Education Act of 1994, in particular, provisions related to Mandatory Product Listing (MPL); and S. 923, Better Mental Health Care for Americans Act, specifically provisions related to substance use disorders. H.R. 831 Medicare Medically Necessary Dental Care Act of 2023 S.842 - Medicare and Medicaid Dental, Vision, and Hearing Benefit Act of 2023; H.R. 6284 Improving Measurements for Loneliness and Isolation Act; H.R. 4150/S.1954 Improving Whole Health for Veterans with Chronic Conditions Act; H.R. 4146 /S.2012 Medicare Dental Benefit Act of 2023 S.3393 SUPPORT for Patients and Communities Reauthorization Act, specifically provisions related to non-opioid alternatives to acute and chronic pain management; and General review of legislation and amendments focusing on non-addictive, non-opioid pain management medications, with a focus on over-the-counter (OTC) options. Monitoring of regulatory proposals impacting inclusion of routine non-pediatric dental services as Essential Health Benefits (EHBs)

Medicare Observation Stays. The Improving Access to Medicare Coverage Act of 2023 (H.R. 5138 and S. 4137): Proposals to count time spent in observation status toward the three-day prior inpatient stay required under Medicare for coverage of a subsequent stay in a skilled nursing facility. Medicare Drug Prices (No bill): Proposal to have the Biden Administration lower the price of the prostate cancer drug Xtandi through executive action by using so-called march-in rights under the Bayh-Dole Act; to amend the Federal Food, Drug, and Cosmetic Act to grant eligible researchers access to drugs or biologic products for research purposes at a price no higher than the cost to the manufacturer; to block so-called Dispense-As-Written campaigns where drug manufacturers incentivize health care providers to specify a brand drug on a prescription to block generic substitution at the pharmacy. Medicare Drug Costs. The Pharmaceutical Research Transparency Act of 2023 (S. 1476 and H.R. 3160): Proposal to amend the Public Health Service Act and the Security Exchange Act to require pharmaceutical manufacturers to report their costs related to clinical trials and research and development. Medicare Drug Savings. The Seniors Securing Access to Vital and Essential Prescription Drugs Act (H.R. 2893): Proposals to discount the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost sharing subsidies under Part D of the Medicare program. (No bills): Proposals to eliminate the Medicare Part D low-income subsidy programs asset test and raise the income eligibility levels to 200 percent of the federal poverty level. Medicare Prescription Drugs. Drug Costs. Inflation Reduction Act (Public Law No: 117-169): Proposal to allow Medicare to negotiate prices with drug makers, cap prices at inflation in Part B and D, cap beneficiary out-of-pocket costs in Part D, eliminate cost-sharing for vaccines, eliminate cost-sharing in the catastrophic phase of Part D, and to raise the income threshold for the Low-Income Subsidy program offering assistance in paying for drugs. Medicare Prescription Drugs. The Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 (H.R. 3093): Proposals to require companies that receive federal funding for research (or a license of the rights to a patent or regulatory test data) for a biomedical product or service to agree to set reasonable prices for the resulting biomedical product or service and authorize to determine a reasonable price based on a formula that ensures the U.S. price for the product or service is not more than the median price for the product or service in Canada and six other reference countries. Medicare Prescription Drugs. (No bill): A regulatory proposal encouraging the Secretaries of the Departments of Health and Human Services (HHS) and Commerce to exercise march in rights that would aim to better control the pricing of prescription drugs. Medicare Prescription Drugs. (No bill): An HHS regulatory proposal to ensure robust negotiation rules and processes that aim to curtail the cost of certain prescription drugs, as authorized by the Inflation Reduction Act (Public Law No: 117-169). Medicare and Medicaid Prescription Drugs. (No bill): Joined comments with 19 other organizations urging HHS to use its existing authority to license competition in order to lower consumer and taxpayer costs for semaglutide drugs treating diabetes and weight management (e.g., Ozempic and Wegovy). Medicare Prescription Drugs. The PACE Part D Choice Act (H.R. 3549 and S. 1703): Proposal to increase the affordability of the Program of All-Inclusive Care for the Elderly (PACE) for Medicare beneficiaries by lowering the cost of Part D premiums substantially for Medicare-only enrollees, thus opening up the PACE program to this population. Medicare Low-Income Subsidy (LIS) Program. (No bill): Proposal to increase funding for LIS outreach and enrollment, so that low-income beneficiaries can more readily access needed medications at prices they can afford. Medicare Reform. The Assuring Medicares Promise Act (H.R. 34) and The Medicare and Social Security Fair Share Act (S. 1174 and H.R. 4535): Proposals to close the loophole for wealthy individuals who bypass paying net investment income tax (NIIT) and directing the revenue to the Hospital Insurance Trust Fund, which pays for Medicare Part A that covers inpatient care in hospitals, and to the Social Security Trust Funds. Medicare Trustees Report (No bill). Review of the findings on economic, legislative and other developments affecting the actuarial soundness of the Medicare Part A (Hospital Insurance) Trust Fund and the Trust Funds for Parts B and D coverage. Medicare Dental Coverage. The Medicare Dental Benefit Act (S. 2012 and H.R. 4146): Proposal to add a dental benefit to Medicare. Medicare Hearing Coverage. The Help Extend Auditory Relief Act of 2024 (H.R. 8064): Proposal to expand Medicare coverage to include hearing examinations and diagnoses, fittings and hearing aids. Medicare call center (No bill): Proposal to address the poor working conditions of the call center workers employed by Maximus, a federal contractor with the Department of Health and Humans Services/Center for Medicare and Medicaid Services) HHS/CMS. Public Health Emergency (No bill): Proposals to ensure the transition out of the public health emergency doesnt create enrollment or coverage gaps for Medicare eligible individuals. Medicare Advantage (MA). (No bill): Proposals to create transparency around Medicare Advantage plans using prior authorization and supplemental benefits that are not offered under traditional Medicare. Medicare Advantage. (No bill): Proposals to apply a higher coding adjustment factor to fully account for intensive upcoding by MA plans and to exclude certain information for MA risk adjustment scores and payments; to use two years of traditional Medicare and MA diagnostic data for calculating MA risk-adjusted payments; and to promulgate more fundamental changes to the Hierarchical Condition Category (HCC) risk adjustment model. Medicare Privatization (No bill): Proposals to create reimbursement policies in traditional Medicare that mimic those used by private health insurance plans. Medicaid Home and Community-Based Services. The HCBS Access Act (H.R. 1493 and S. 762): Proposals to make home and community-based services (HCBS) a mandatory benefit within Medicaid, and to ensure eligible older adults and people with disabilities have the option to choose between home care and institutional care. Caregiving. The Alleviating Barriers to Caregiving Act (H.R. 8018 and S. 3109): Proposal to require the Secretaries of HHS and SSA to review and streamline enrollment in coverage and benefits for family caregivers in Medicare, Medicaid, CHIP and Social Security. Medicare and Medicaid Nursing Homes. The Nursing Home Disclosure Act (H.R. 177): Proposal to direct HHS to establish a national registry of medical directors. Medicare, Medicaid Nursing Homes. The Protecting Americas Seniors Access to Care Act (H.R. 7513 and S. 3410): Proposal to prohibit the HHS Secretary from promulgating national staffing standards in nursing homes. Medicare, Medicaid Nursing Homes. (H.J. Res. 139 and S.J. Res. 91): Proposal to use the Congressional Review Act to disapprove the HHS Secretarys final rule promulgating national staffing standards in nursing homes Medicare, Medicaid Nursing Homes. The Building Americas Health Care Workforce Act (H.R. 9067): Proposal to allow time spent working in a nursing home (prior to any formal training, and permitted during the COVID-19 pandemic) to count toward a 75-hour minimum federal training standard that is required for certified nursing assistants. Medicare, Medicaid Nursing Homes. The Ensuring Seniors Access to Quality Care Act (H.R. 3227): Proposal to repeal regulations that prohibit certified nursing assistant training and competency evaluation programs in skilled nursing facilities that have a record of health and safety deficiencies and have incurred penalties (e.g., civil monetary penalties for substandard quality of care). Medicare, Medicaid Nursing Homes, Assisted Living and Other Long Term Care Services and Supports (LTSS) Settings. The Long-Term Care Workforce Support Act (H.R. 7994 and S. 4120): Proposals to increase the number of direct care professionals, including in rural communities; pathways to enter and be supported in the workforce for women, people of color, and people with disabilities; and to improve compensation for direct care professionals to reduce vacancies and turnover. Medicare and Medicaid Nursing Home Ownership. (No bill): A final HHS regulation for comprehensive ownership disclosure in the nursing home sector issued on November 17th, 2023. Rule calls for strengthened cost reporting requirements, together with ongoing national analyses and monitoring of the performance of the nursing home sector that uses ownership, staffing, cost report data and inspection data. Medicare and Medicaid Nursing Home Staffing. (No bill): Final regulations establishing national staffing standards in nursing homes that would safeguard the health and safety of all elderly and disabled residents. Medicaid Long-Term Services and Supports (LTSS). (No bill): Proposals to request that CMS collect standardized LTSS expenditure data annually from every state and across all LTSS programs and for disaggregation of expenditure data by the delivery system and demographic characteristics in order to identify disparities in access and use of LTSS and help states and CMS deploy targeted strategies to meet the needs of older adults and people with disabilities. Oversight of Health Care Industry Owned by Private Equity Firms. (No bill): Joined with other organizations in submitting comments (April 2024) to HHS, the Federal Trade Commission and the Department of Justice urging sustained, stepped up and rigorous oversight be extended to health care industry transactions that are financed by private equity company companies and other types of private investors.

Medicare Dental Benefit Act (H.R. 4146, S. 2012), Medicare Dental, Vision and Hearing Benefit Act (H.R. 33), Medicare Heart Aid Act (H.R. 244), Beneficiary Enrollment Notification and Eligibility Act 2.0 (S. 1687), Preserve Access to Affordable Generics and Biosimilars Act (S. 142).

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Sustaining Outpatient Services Act (H.R. 955/S. 1849) Regulations from the Executive in Need of Scrutiny (REINS) Act of 2023 (HR 277/S 184) Increasing Access to Quality Cardiac Rehabilitative Care Act (HR 2583/S. 3481) Black Maternal Health Momnibus Act (S. 1606/HR 3305) Medicare Dental Benefit Act (HR 4146/S. 2012) Accelerating Kids Access to Care Act (H.R. 4758/S. 2372) Amputation Reduction and Compassion Act (H.R. 4261) CONNECT for Health Act (S. 2016, H.R. 4189) Kickstarting Innovative Demonstrations Supporting (KIDS) Health Act of 2023 (HR 3805/ S. 1769) Expanding Remote Monitoring Access Act (H.R.5394) Physical Activity Omnibus Legislation (No Bill Number) Preventing Maternal Deaths Reauthorization Act of 2023 (H.R. 3838/S. 2415) PREEMIE Reauthorization Act of 2023 (H.R. 3226/S. 1573) Sustainable Cardiopulmonary Rehabilitation Services in the Home Act (S. 3021) Supporting Innovation for Seniors Act (H.R. 5388) Supporting Patient Education And Knowledge (SPEAK) Act of 2023 (H.R. 6033) Wearable Equipment Adoption and Reinforcement and Investment in Technology (WEAR IT) Act (H.R. 6279) Telehealth Modernization Act (H.R.7623/S.3967) Patient Matching in Certified Health IT (Match IT) Act (H.R.7379) To Prevent Diabetes Act (H.R.7856) Medically Tailored Home-Delivered Meals Demonstration Pilot (H.R. 7680/S.2133) 2025 Notice of Benefit and Payment Parameters HHS finalization of proposed rule on Streamlining the Medicaid, Childrens Health Insurance Program, and Basic Health Program Application, Eligibility Determination, Enrollment, and Renewal Processes; Proposed Rule (CMS-2421-P) HHS finalization of proposed rules Ensuring Access to Medicaid Services (CMS-2442-P) and Medicaid and Childrens Health Insurance Program Managed Care Access, Finance and Quality (CMS-2439-P) HHS finalization of proposed rule on Mental Health Parity; Requirements Related to the Mental Health Parity and Addiction Equity Act (MHPAEA) (CMS-9902-P) and Processes for Assessing Compliance with Mental Health Parity and Addiction Equity in Medicaid and CHIP HHS interim final rule on CMS Enforcement of State Compliance with Reporting and Federal Medicaid Renewal Requirements Under Section 1902(t) of the Social Security Act (CMS-2447-IFC) Medicare coverage of self-monitored blood pressure devices

Medicare Observation Stays. The Improving Access to Medicare Coverage Act of 2023 (H.R. 5138 and S. 4137): Proposals to count time spent in observation status toward the three-day prior inpatient stay required under Medicare for coverage of a subsequent stay in a skilled nursing facility. Medicare Drug Prices (No bill): Proposal to have the Biden Administration lower the price of the prostate cancer drug Xtandi through executive action by using so-called march-in rights under the Bayh-Dole Act; to amend the Federal Food, Drug, and Cosmetic Act to grant eligible researchers access to drugs or biologic products for research purposes at a price no higher than the cost to the manufacturer; to block so-called Dispense-As-Written campaigns where drug manufacturers incentivize health care providers to specify a brand drug on a prescription to block generic substitution at the pharmacy. Medicare Drug Costs. The Pharmaceutical Research Transparency Act of 2023 (S. 1476 and H.R. 3160): Proposal to amend the Public Health Service Act and the Security Exchange Act to require pharmaceutical manufacturers to report their costs related to clinical trials and research and development. Medicare Drug Savings. The Seniors Securing Access to Vital and Essential Prescription Drugs Act (H.R. 2893): Proposals to discount the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost sharing subsidies under Part D of the Medicare program. (No bills): Proposals to eliminate the Medicare Part D low-income subsidy programs asset test and raise the income eligibility levels to 200 percent of the federal poverty level. Medicare Prescription Drugs. Drug Costs. Inflation Reduction Act (Public Law No: 117-169): Proposal to allow Medicare to negotiate prices with drug makers, cap prices at inflation in Part B and D, cap beneficiary out-of-pocket costs in Part D, eliminate cost-sharing for vaccines, eliminate cost-sharing in the catastrophic phase of Part D, and to raise the income threshold for the Low-Income Subsidy program offering assistance in paying for drugs. Medicare Prescription Drugs. The Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 (H.R. 3093): Proposals to require companies that receive federal funding for research (or a license of the rights to a patent or regulatory test data) for a biomedical product or service to agree to set reasonable prices for the resulting biomedical product or service and authorize to determine a reasonable price based on a formula that ensures the U.S. price for the product or service is not more than the median price for the product or service in Canada and six other reference countries. Medicare Prescription Drugs. (No bill): A regulatory proposal encouraging the Secretaries of the Departments of Health and Human Services (HHS) and Commerce to exercise march in rights that would aim to better control the pricing of prescription drugs. Medicare Prescription Drugs. (No bill): An HHS regulatory proposal to ensure robust negotiation rules and processes that aim to curtail the cost of certain prescription drugs, as authorized by the Inflation Reduction Act. Medicare Low-Income Subsidy (LIS) Program. (No bill): Proposal to increase funding for LIS outreach and enrollment, so that low-income beneficiaries can more readily access needed medications at prices they can afford. Medicare Reform. The Assuring Medicares Promise Act (H.R. 34) and The Medicare and Social Security Fair Share Act (S. 1174 and H.R. 4535): Proposals to close the loophole for wealthy individuals who bypass paying net investment income tax (NIIT) and directing the revenue to the Hospital Insurance Trust Fund, which pays for Medicare Part A that covers inpatient care in hospitals, and to the Social Security Trust Funds. Medicare Dental Coverage. The Medicare Dental Benefit Act (S. 2012 and H.R. 4146): Proposal to add a dental benefit to Medicare. Medicare Hearing Coverage. The Medicare Hearing Aid Coverage Act of 2021 (H.R. 244): Proposal to expand Medicare coverage to include hearing aids and services for seniors under Medicare Part B. Medicare call center (No bill): Proposal to address the poor working conditions of the call center workers employed by Maximus, a federal contractor with the Department of Health and Humans Services/Center for Medicare and Medicaid Services) HHS/CMS. Public Health Emergency (No bill): Proposals to ensure the transition out of the public health emergency doesnt create enrollment or coverage gaps for Medicare eligible individuals. Medicare Advantage (MA). (No bill): Proposals to create transparency around Medicare Advantage plans using prior authorization and supplemental benefits that are not offered under traditional Medicare. Medicare Advantage. (No bill): Proposals to apply a higher coding adjustment factor to fully account for intensive upcoding by MA plans and to exclude certain information for MA risk adjustment scores and payments; to use two years of traditional Medicare and MA diagnostic data for calculating MA risk-adjusted payments; and to promulgate more fundamental changes to the Hierarchical Condition Category (HCC) risk adjustment model. Medicare Privatization (No bill): Proposals to create reimbursement policies in traditional Medicare that mimic those used by private health insurance plans. Medicaid Home And Community-Based Services. The HCBS Access Act (H.R. 1493 and S. 762): Proposals to make home and community-based services (HCBS) a mandatory benefit within Medicaid, and to ensure eligible older adults and people with disabilities have the option to choose between home care and institutional care. Caregiving. The Alleviating Barriers to Caregiving Act (H.R. 8018 and S. 3109): Proposal to require the Secretaries of HHS and SSA to review and streamline enrollment in coverage and benefits for family caregivers in Medicare, Medicaid, CHIP and Social Security. Medicare and Medicaid Nursing Homes. The Nursing Home Disclosure Act (H.R. 177): Proposal to direct HHS to establish a national registry of medical directors. Medicare, Medicaid Nursing Homes. The Protecting Americas Seniors Access to Care Act (H.R. 7513 and S. 3410): Proposal to prohibit the HHS Secretary from promulgating national staffing standards in nursing homes. Medicare, Medicaid Nursing Homes. (H.J. Res. 139 and S.J. Res. 91): Proposal to use the Congressional Review Act to disapprove the HHS Secretarys final rule promulgating national staffing standards in nursing homes Medicare, Medicaid Nursing Homes, Assisted Living and Other Long Term Care Services and Supports (LTSS) Settings. The Long-Term Care Workforce Support Act (H.R. 7994 and S. 4120): Proposal to increase the number of direct care professionals, including in rural communities; pathways to enter and be supported in the workforce for women, people of color, and people with disabilities; and to improve compensation for direct care professionals to reduce vacancies and turnover. Medicare and Medicaid Nursing Home Ownership. (No bill): A proposed final HHS regulation for comprehensive ownership disclosure in the nursing home sector issued on November 17th, 2023. Rule calls for strengthened cost reporting requirements, together with ongoing national analyses and monitoring of the performance of the nursing home sector that uses ownership, staffing, cost report data and inspection data. Medicare and Medicaid Nursing Home Staffing. (No bill): Final regulations establishing national staffing standards in nursing homes that would safeguard the health and safety of all elderly and disabled residents. Medicaid Long-Term Services and Supports (LTSS). (No bill): Proposal to request that CMS collect standardized LTSS expenditure data annually from every state and across all LTSS programs and for disaggregation of expenditure data by the delivery system and demographic characteristics in order to identify disparities in access and use of LTSS and help states and CMS deploy targeted strategies to meet the needs of older adults and people with disabilities.

General monitoring of legislative and administrative action related to health care policy; General monitoring of legislative and administrative action related to womens health issues; General monitoring of legislative and administrative action related to over-the-counter consumer healthcare products; General monitoring of legislative and administrative action related to dietary supplements, multivitamin, and hunger issues; General monitoring of legislative and administrative action related to servicing of medical device equipment; General monitoring of legislative and administrative action related to the Supplemental Nutrition Assistance Program (SNAP); General monitoring of legislative and administrative action related to FDA monograph reform and user fees; General monitoring of legislative and administrative action related to the switch of prescription medications to over-the-counter medications; Review of issues related to Prescription Drug User Fee Act Reauthorization (PDUFA); Review of coverage for medically necessary services in Medicare and Medicare Advantage, including dental coverage, to address underlying conditions in advance of major surgery; General review and monitoring of processes impacting over-the-counter switches, including Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU) rulemaking process Monitor and engage on legislative and administrative action related to phenylephrine and pseudoephedrine regulation. General monitoring of issues related to the reauthorization of "Pandemic and All-Hazards Preparedness Act" PAHPA S. 818 Maximizing Opioid Recovery Emergency Savings Act, in particular, provisions related to drugs and biologicals; Review of legislation impacting the Dietary Supplement Health and Education Act of 1994, in particular, provisions related to Mandatory Product Listing (MPL); and S. 923, Better Mental Health Care for Americans Act, specifically provisions related to substance use disorders. H.R. 831 Medicare Medically Necessary Dental Care Act of 2023 S.842 - Medicare and Medicaid Dental, Vision, and Hearing Benefit Act of 2023; H.R. 6284 Improving Measurements for Loneliness and Isolation Act; H.R. 4150/S.1954 Improving Whole Health for Veterans with Chronic Conditions Act; H.R. 4146 /S.2012 Medicare Dental Benefit Act of 2023 S.3393 SUPPORT for Patients and Communities Reauthorization Act, specifically provisions related to non-opioid alternatives to acute and chronic pain management; and General review of legislation and amendments focusing on non-addictive, non-opioid pain management medications, with a focus on over-the-counter (OTC) options. Monitoring of regulatory proposals impacting inclusion of routine non-pediatric dental services as Essential Health Benefits (EHBs)

Medicare Dental Benefit Act (H.R. 4146, S. 2012), Medicare Dental, Vision and Hearing Benefit Act (H.R. 33), Medicare Heart Aid Act (H.R. 244), Beneficiary Enrollment Notification and Eligibility Act 2.0 (S. 1687), Preserve Access to Affordable Generics and Biosimilars Act (S. 142).

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Dental Benefit Act (H.R. 4146, S. 2012), Medicare Dental, Vision and Hearing Benefit Act (H.R. 33), Medicare Heart Aid Act (H.R. 244), Beneficiary Enrollment Notification and Eligibility Act 2.0 (S. 1687), Preserve Access to Affordable Generics and Biosimilars Act (S. 142).

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Sustaining Outpatient Services Act (H.R. 955/S. 1849) Regulations from the Executive in Need of Scrutiny (REINS) Act of 2023 (HR 277/S 184) Increasing Access to Quality Cardiac Rehabilitative Care Act (HR 2583/S. 3481) Black Maternal Health Momnibus Act (S. 1606/HR 3305) Medicare Dental Benefit Act (HR 4146/S. 2012) Accelerating Kids Access to Care Act (H.R. 4758/S. 2372) Amputation Reduction and Compassion Act (H.R. 4261) CONNECT for Health Act (S. 2016, H.R. 4189) Kickstarting Innovative Demonstrations Supporting (KIDS) Health Act of 2023 (HR 3805/ S. 1769) Expanding Remote Monitoring Access Act (H.R.5394) Physical Activity Omnibus Legislation (No Bill Number) Preventing Maternal Deaths Reauthorization Act of 2023 (H.R. 3838/S. 2415) PREEMIE Reauthorization Act of 2023 (H.R. 3226/S. 1573) Sustainable Cardiopulmonary Rehabilitation Services in the Home Act (S. 3021) Supporting Innovation for Seniors Act (H.R. 5388) Supporting Patient Education And Knowledge (SPEAK) Act of 2023 (H.R. 6033) Wearable Equipment Adoption and Reinforcement and Investment in Technology (WEAR IT) Act (H.R. 6279) Telehealth Modernization Act (H.R.7623/S.3967) Patient Matching in Certified Health IT (Match IT) Act (H.R.7379) To Prevent Diabetes Act (H.R.7856) 2025 Notice of Benefit and Payment Parameters HHS finalization of proposed rule on Streamlining the Medicaid, Childrens Health Insurance Program, and Basic Health Program Application, Eligibility Determination, Enrollment, and Renewal Processes; Proposed Rule (CMS-2421-P) HHS finalization of proposed rules Ensuring Access to Medicaid Services (CMS-2442-P) and Medicaid and Childrens Health Insurance Program Managed Care Access, Finance and Quality (CMS-2439-P) HHS finalization of proposed rule on Mental Health Parity; Requirements Related to the Mental Health Parity and Addiction Equity Act (MHPAEA) (CMS-9902-P) and Processes for Assessing Compliance with Mental Health Parity and Addiction Equity in Medicaid and CHIP HHS interim final rule on CMS Enforcement of State Compliance with Reporting and Federal Medicaid Renewal Requirements Under Section 1902(t) of the Social Security Act (CMS-2447-IFC)

Medicare Observation Stays. Improving Access to Medicare Coverage Act of 2023 (H.R. 5138): Proposals to count time spent in observation status toward the three-day prior inpatient stay required under Medicare for coverage of a subsequent stay in a skilled nursing facility. Medicare Drug Prices (No bill): Proposal to have the Biden Administration lower the price of the prostate cancer drug Xtandi through executive action by using so-called march-in rights under the Bayh-Dole Act; to amend the Federal Food, Drug, and Cosmetic Act to grant eligible researchers access to drugs or biologic products for research purposes at a price no higher than the cost to the manufacturer; to block so-called Dispense-As-Written campaigns where drug manufacturers incentivize health care providers to specify a brand drug on a prescription to block generic substitution at the pharmacy. Medicare Drug Costs. Pharmaceutical Research Transparency Act of 2023 (S. 1476 and H.R. 3160): Proposal to amend the Public Health Service Act and the Security Exchange Act to require pharmaceutical manufacturers to report their costs related to clinical trials and research and development. Medicare Drug Savings. Seniors Securing Access to Vital and Essential Prescription Drugs Act (H.R. 2893): Proposals to discount the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost sharing subsidies under Part D of the Medicare program. (No bills): Proposals to eliminate the Medicare Part D low-income subsidy programs asset test and raise the income eligibility levels to 200 percent of the federal poverty level. Medicare Prescription Drugs. Drug Costs. Inflation Reduction Act (Public Law No: 117-169): Proposal to allow Medicare to negotiate prices with drug makers, cap prices at inflation in Part B and D, cap beneficiary out-of-pocket costs in Part D, eliminate cost-sharing for vaccines, eliminate cost-sharing in the catastrophic phase of Part D, and to raise the income threshold for the Low-Income Subsidy program offering assistance in paying for drugs. Medicare Prescription Drugs. Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 (H.R. 3093): Proposals to require companies that receive federal funding for research (or a license of the rights to a patent or regulatory test data) for a biomedical product or service to agree to set reasonable prices for the resulting biomedical product or service and authorize to determine a reasonable price based on a formula that ensures the U.S. price for the product or service is not more than the median price for the product or service in Canada and six other reference countries. Medicare Prescription Drugs. (No bill): A regulatory proposal encouraging the Secretaries of the Departments of Health and Human Services (HHS) and Commerce to exercise march in rights that would aim to better control the pricing of prescription drugs. Medicare Prescription Drugs. (No bill): An HHS regulatory proposal to ensure robust negotiation rules and processes that aim to curtail the cost of certain prescription drugs, as authorized by the Inflation Reduction Act. Medicare Low-Income Subsidy (LIS) Program. (No bill): Proposal to increase funding for LIS outreach and enrollment, so that low-income beneficiaries can more readily access needed medications at prices they can afford. Medicare Reform. Assuring Medicares Promise Act (H.R. 34) and Medicare and Social Security Fair Share Act (S. 1174 and H.R. 4535): Proposals to close the loophole for wealthy individuals who bypass paying net investment income tax (NIIT) and directing the revenue to the Hospital Insurance Trust Fund, which pays for Medicare Part A that covers inpatient care in hospitals, and to the Social Security Trust Funds. Medicare Dental Coverage. Medicare Dental Benefit Act (S. 2012 and H.R. 4146): Proposal to add a dental benefit to Medicare. Medicare Hearing Coverage. The Medicare Hearing Aid Coverage Act of 2021 (H.R. 244): Proposal to expand Medicare coverage to include hearing aids and services for seniors under Medicare Part B. Medicare call center (No bill): Proposal to address the poor working conditions of the call center workers employed by Maximus, a federal contractor with the Department of Health and Humans Services/Center for Medicare and Medicaid Services) HHS/CMS. Public Health Emergency (No bill): Proposals to ensure the transition out of the public health emergency doesnt create enrollment or coverage gaps for Medicare eligible individuals. Medicare Advantage (MA). (No bill): Proposals to create transparency around Medicare Advantage plans using prior authorization and supplemental benefits that are not offered under traditional Medicare. Medicare Advantage. (No bill): Proposals to apply a higher coding adjustment factor to fully account for intensive upcoding by MA plans and to exclude certain information for MA risk adjustment scores and payments; to use two years of traditional Medicare and MA diagnostic data for calculating MA risk-adjusted payments; and to promulgate more fundamental changes to the Hierarchical Condition Category (HCC) risk adjustment model. Medicare Privatization (No bill): Proposals to create reimbursement policies in traditional Medicare that mimic those used by private health insurance plans. Medicaid Home And Community-Based Services. HCBS Access Act (H.R. 1493 and S. 762): Proposals to make home and community-based services (HCBS) a mandatory benefit within Medicaid, and to ensure eligible older adults and people with disabilities have the option to choose between home care and institutional care. Medicare and Medicaid Nursing Homes. Nursing Home Disclosure Act (H.R. 177): Proposal to direct HHS to establish a national registry of medical directors. Medicare, Medicaid Nursing Homes. Protecting Americas Seniors Access to Care Act (H.R. 7513): Proposal to prohibit the HHS Secretary from promulgating national staffing standards in nursing homes. Medicare, Medicaid Nursing Homes, Assisted Living and Other LTSS Settings. Long-Term Care Workforce Support Act (No bill number): Proposal to increase the number of direct care professionals, including in rural communities; pathways to enter and be supported in the workforce for women, people of color, and people with disabilities; and to improve compensation for direct care professionals to reduce vacancies and turnover. Medicare and Medicaid Nursing Home Ownership. (No bill): A proposed final HHS regulation for comprehensive ownership disclosure in the nursing home sector issued on November 17th, 2023. Rule calls for strengthened cost reporting requirements, together with ongoing national analyses and monitoring of the performance of the nursing home sector that uses ownership, staffing, cost report data and inspection data. Medicare and Medicaid Nursing Home Staffing. (No bill): A proposed CMS final regulations for establishing national staffing standards in nursing homes that would safeguard the health and safety of all elderly and disabled residents. Medicaid Long-Term Services and Supports (LTSS). (No bill): Proposal to request that CMS collect standardized LTSS expenditure data annually from every state and across all LTSS programs and for disaggregation of expenditure data by the delivery system and demographic characteristics in order to identify disparities in access and use of LTSS and help states and CMS deploy targeted strategies to meet the needs of older adults and people with disabilities.

General monitoring of legislative and administrative action related to health care policy; General monitoring of legislative and administrative action related to womens health issues; General monitoring of legislative and administrative action related to over-the-counter consumer healthcare products; General monitoring of legislative and administrative action related to dietary supplements, multivitamin, and hunger issues; General monitoring of legislative and administrative action related to servicing of medical device equipment; General monitoring of legislative and administrative action related to the Supplemental Nutrition Assistance Program (SNAP); General monitoring of legislative and administrative action related to FDA monograph reform and user fees; General monitoring of legislative and administrative action related to the switch of prescription medications to over-the-counter medications; Review of issues related to Prescription Drug User Fee Act Reauthorization (PDUFA); Review of coverage for medically necessary services in Medicare and Medicare Advantage, including dental coverage, to address underlying conditions in advance of major surgery; General review and monitoring of processes impacting over-the-counter switches, including Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU) rulemaking process Monitor and engage on legislative and administrative action related to phenylephrine and pseudoephedrine regulation. General monitoring of issues related to the reauthorization of "Pandemic and All-Hazards Preparedness Act" PAHPA S. 818 Maximizing Opioid Recovery Emergency Savings Act, in particular, provisions related to drugs and biologicals; Review of legislation impacting the Dietary Supplement Health and Education Act of 1994, in particular, provisions related to Mandatory Product Listing (MPL); and S. 923, Better Mental Health Care for Americans Act, specifically provisions related to substance use disorders. H.R. 831 Medicare Medically Necessary Dental Care Act of 2023 S.842 - Medicare and Medicaid Dental, Vision, and Hearing Benefit Act of 2023; H.R. 6284 Improving Measurements for Loneliness and Isolation Act; H.R. 4150/S.1954 Improving Whole Health for Veterans with Chronic Conditions Act; H.R. 4146 /S.2012 Medicare Dental Benefit Act of 2023 S.3393 SUPPORT for Patients and Communities Reauthorization Act, specifically provisions related to non-opioid alternatives to acute and chronic pain management; and General review of legislation and amendments focusing on non-addictive, non-opioid pain management medications, with a focus on over-the-counter (OTC) options. Monitoring of regulatory proposals impacting inclusion of routine non-pediatric dental services as Essential Health Benefits (EHBs)

Sustaining Outpatient Services Act (H.R. 955/S. 1849) Regulations from the Executive in Need of Scrutiny (REINS) Act of 2023 (HR 277/S 184) Increasing Access to Quality Cardiac Rehabilitative Care Act (HR 2583/S. 3481) Black Maternal Health Momnibus Act (S. 1606/HR 3305) Medicare Dental Benefit Act (HR 4146/S. 2012) Accelerating Kids Access to Care Act (H.R. 4758/S. 2372) Amputation Reduction and Compassion Act (H.R. 4261) CONNECT for Health Act (S. 2016, H.R. 4189) Kickstarting Innovative Demonstrations Supporting (KIDS) Health Act of 2023 (HR 3805/ S. 1769) Expanding Remote Monitoring Access Act (H.R.5394) Physical Activity Omnibus Legislation (No Bill Number) Preventing Maternal Deaths Reauthorization Act of 2023 (H.R. 3838/S. 2415) PREEMIE Reauthorization Act of 2023 (H.R. 3226/S. 1573) Sustainable Cardiopulmonary Rehabilitation Services in the Home Act (S. 3021) Supporting Innovation for Seniors Act (H.R. 5388) Supporting Patient Education And Knowledge (SPEAK) Act of 2023 (H.R. 6033) Wearable Equipment Adoption and Reinforcement and Investment in Technology (WEAR IT) Act (H.R. 6279)

Client expense: $170,000 · Firm income: Not reported

Medicare Observation Stays. Improving Access to Medicare Coverage Act of 2023 (H.R. 5138): Proposals to count time spent in observation status toward the three-day prior inpatient stay required under Medicare for coverage of a subsequent stay in a skilled nursing facility. Medicare Drug Prices (No bill): Proposal to have the Biden Administration lower the price of the prostate cancer drug Xtandi through executive action by using so-called march-in rights under the Bayh-Dole Act; to amend the Federal Food, Drug, and Cosmetic Act to grant eligible researchers access to drugs or biologic products for research purposes at a price no higher than the cost to the manufacturer; to block so-called Dispense-As-Written campaigns where drug manufacturers incentivize health care providers to specify a brand drug on a prescription to block generic substitution at the pharmacy. Medicare Drug Costs. Pharmaceutical Research Transparency Act of 2023 (S. 1476 and H.R. 3160): Proposal to amend the Public Health Service Act and the Security Exchange Act to require pharmaceutical manufacturers to report their costs related to clinical trials and research and development. Medicare Drug Savings. Seniors Securing Access to Vital and Essential Prescription Drugs Act (H.R. 2893): Proposals to discount the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost sharing subsidies under Part D of the Medicare program. (No bills): Proposals to eliminate the Medicare Part D low-income subsidy programs asset test and raise the income eligibility levels to 200 percent of the federal poverty level. Medicare Prescription Drugs. Drug Costs. Inflation Reduction Act (Public Law No: 117-169): Proposal to allow Medicare to negotiate prices with drug makers, cap prices at inflation in Part B and D, cap beneficiary out-of-pocket costs in Part D, eliminate cost-sharing for vaccines, eliminate cost-sharing in the catastrophic phase of Part D, and raise the income threshold for the low-income subsidy. Medicare Prescription Drugs. Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 (H.R. 3093): Proposes to require companies that receive federal funding for research (or a license of the rights to a patent or regulatory test data) for a biomedical product or service to agree to set reasonable prices for the resulting biomedical product or service and authorize to determine a reasonable price based on a formula that ensures the U.S. price for the product or service is not more than the median price for the product or service in Canada and six other reference countries with, based on specified criteria, large economies and high incomes. Medicare Prescription Drugs. (No bill) Supported an administrative proposal encouraging the Secretaries of the Departments of Health and Human Services (HHS) and Commerce to exercise march in rights that would aim to better control the pricing of prescription drugs. Medicare Prescription Drugs. (No bill) Supported HHS promulgating robust negotiation rules and processes that aim to curtail the cost of certain prescription drugs, as authorized by the Inflation Reduction Act. Medicare Low-Income Subsidy (LIS) Program. (No bill) Supported increased funding for LIS outreach and enrollment, so that low-income beneficiaries can more readily access needed medications at prices they can afford. Medicare Reform. Assuring Medicares Promise Act (H.R. 34) and Medicare and Social Security Fair Share Act (S. 1174 and H.R 4535): Proposals to close the loophole for wealthy individuals who bypass paying net investment income tax (NIIT) and directing the revenue to the Hospital Insurance Fund, which pays for Medicare Part A that covers inpatient care in hospitals, and to the Social Security Trust Funds. Medicare Dental Coverage. Medicare Dental Benefit Act (S. 2012 and H.R. 4146): Proposal to add a dental benefit to Medicare. Medicare Hearing Coverage. The Medicare Hearing Aid Coverage Act of 2021 (H.R. 244): Proposal to expand Medicare coverage to include hearing aids and services for seniors under Part B of the Medicare program. Medicare call center (No bill): Proposal to address the poor working conditions of the call center workers employed by Maximus, a federal contractor with the Department of Health and Humans Services/Center for Medicare and Medicaid Services) HHS/CMS. Public Health Emergency (No bill): Proposals to ensure the transition out of the public health emergency doesnt create enrollment or coverage gaps for Medicare eligible individuals. Medicare Advantage. (No bill): Proposals to create transparency around Medicare Advantage plans using prior authorization and supplemental benefits that are not offered under traditional Medicare. Medicare Privatization (No bill): Proposals to create reimbursement policies in traditional Medicare that mimic those used by private health insurance plans. Medicaid Home And Community-Based Services. Inflation Reduction Act (Public Law No: 117-169): Proposals to expand Medicaid home and community-based services and the Medicare savings programs. Medicaid Home And Community-Based Services. HCBS Access Act (H.R. 1493 and S. 762). Proposals to make home and community-based services (HCBS) a mandatory benefit within Medicaid, and to ensure eligible older adults and people with disabilities have the option to choose between home care and institutional care. Medicare and Medicaid Nursing Homes. Nursing Home Disclosure Act (H.R. 177). Proposal to direct HHS to establish a national registry of medical directors. Medicare and Medicaid Nursing Home Ownership. (No bill) Supporting the final HHS regulations for comprehensive ownership disclosure in the nursing home sector issued on November 17th, 2023. Calling for strengthened cost reporting requirements, together with ongoing national analyses and monitoring of the performance of the nursing home sector that uses ownership, staffing, cost report data and inspection data. Medicare and Medicaid Nursing Home Staffing. (No bill) Support for CMS to promulgate improved final regulations for establishing national staffing standards in nursing homes that would safeguard the health and safety of all elderly and disabled residents. Medicaid Long-Term Services and Supports (LTSS). (No bill): To request that CMS collect standardized LTSS expenditure data annually from every state and across all LTSS programs and for disaggregation of expenditure data by the delivery system and demographic characteristics in order to identify disparities in access and use of LTSS and help states and CMS deploy targeted strategies to meet the needs of older adults and people with disabilities.

General monitoring of legislative and administrative action related to health care policy; General monitoring of legislative and administrative action related to womens health issues; General monitoring of legislative and administrative action related to over-the-counter consumer healthcare products; General monitoring of legislative and administrative action related to dietary supplements, multivitamin, and hunger issues; General monitoring of legislative and administrative action related to servicing of medical device equipment; General monitoring of legislative and administrative action related to the Supplemental Nutrition Assistance Program (SNAP); General monitoring of legislative and administrative action related to FDA monograph reform and user fees; General monitoring of legislative and administrative action related to the switch of prescription medications to over-the-counter medications; Review of issues related to Prescription Drug User Fee Act Reauthorization (PDUFA); Review of coverage for medically necessary services in Medicare and Medicare Advantage, including dental coverage, to address underlying conditions in advance of major surgery; General review and monitoring of processes impacting over-the-counter switches, including Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU) rulemaking process Monitor and engage on legislative and administrative action related to phenylephrine and pseudoephedrine regulation. General monitoring of issues related to the reauthorization of "Pandemic and All-Hazards Preparedness Act" PAHPA S. 818 Maximizing Opioid Recovery Emergency Savings Act, in particular, provisions related to drugs and biologicals; Review of legislation impacting the Dietary Supplement Health and Education Act of 1994, in particular, provisions related to Mandatory Product Listing (MPL); and S. 923, Better Mental Health Care for Americans Act, specifically provisions related to substance use disorders. H.R. 831 Medicare Medically Necessary Dental Care Act of 2023 S.842 - Medicare and Medicaid Dental, Vision, and Hearing Benefit Act of 2023; H.R. 6284 Improving Measurements for Loneliness and Isolation Act; H.R. 4150/S.1954 Improving Whole Health for Veterans with Chronic Conditions Act; H.R. 4146 /S.2012 Medicare Dental Benefit Act of 2023 S.3393 SUPPORT for Patients and Communities Reauthorization Act, specifically provisions related to non-opioid alternatives to acute and chronic pain management; and General review of legislation and amendments focusing on non-addictive, non-opioid pain management medications, with a focus on over-the-counter (OTC) options.

Medicare Dental Benefit Act (H.R. 4146, S. 2012), Medicare Dental, Vision and Hearing Benefit Act (H.R. 33), Medicare Heart Aid Act (H.R. 244), Beneficiary Enrollment Notification and Eligibility Act 2.0 (S. 1687), Preserve Access to Affordable Generics and Biosimilars Act (S. 142).

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prohibiting copay accumulators in ACA Exchange plans: H.R. 830 - Help Ensure Lower Patient (HELP) Copays Act; Strengthen Medicare Part D Low Income Subsidy Program; Create dental benefit under Medicare; Medicare Dental Benefit Act (H.R. 4146 / S. 2012); Safe Step Act (H.R. 2630/S. 652); Telehealth Expansion Act (H.R. 1843 / S.1001); Cancer Parity Drug Act (S. 2093)

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Sustaining Outpatient Services Act (H.R. 955/S. 1849) Regulations from the Executive in Need of Scrutiny (REINS) Act of 2023 (HR 277/S 184) Increasing Access to Quality Cardiac Rehabilitative Care Act (HR 2583) Black Maternal Health Momnibus Act (S. 1606/HR 3305) Medicare Dental Benefit Act (HR 4146/S. 2012) Accelerating Kids Access to Care Act (H.R. 4758/S. 2372) Amputation Reduction and Compassion Act (H.R. 4261) CONNECT for Health Act (S. 2016, H.R. 4189) Kickstarting Innovative Demonstrations Supporting (KIDS) Health Act of 2023 (HR 3805/ S. 1769) Expanding Remote Monitoring Access Act (H.R.5394) Physical Activity Omnibus Legislation (No Bill Number) Preventing Maternal Deaths Reauthorization Act of 2023 (H.R. 3838/S. 2415) PREEMIE Reauthorization Act of 2023 (H.R. 3226/S. 1573) Short-Term, Limited Duration Health Plans Rule Policies in the 2024 Physician Fee Schedule Policies in the 2024 Hospital Outpatient Prospective Payment System Rule Medicare National Coverage Determination of Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting

Client expense: $130,000 · Firm income: Not reported

Medicare Observation Stays. Improving Access to Medicare Coverage Act of 2023 (H.R. 5138): Proposals to count time spent in observation status toward the three-day prior inpatient stay required under Medicare for coverage of a subsequent stay in a skilled nursing facility. Medicare Drug Prices (No bill): Proposal to have the Biden Administration lower the price of the prostate cancer drug Xtandi through executive action by using so-called march-in rights under the Bayh-Dole Act; to amend the Federal Food, Drug, and Cosmetic Act to grant eligible researchers access to drugs or biologic products for research purposes at a price no higher than the cost to the manufacturer; to block so-called Dispense-As-Written campaigns where drug manufacturers incentivize health care providers to specify a brand drug on a prescription to block generic substitution at the pharmacy. Medicare Drug Costs. Pharmaceutical Research Transparency Act of 2023 (S. 1476 and H.R. 3160): Proposal to amend the Public Health Service Act and the Security Exchange Act to require pharmaceutical manufacturers to report their costs related to clinical trials and research and development. Medicare Drug Savings. Seniors Securing Access to Vital and Essential Prescription Drugs Act (H.R. 2893): Proposals to discount the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost sharing subsidies under Part D of the Medicare program. (No bills): Proposals to eliminate the Medicare Part D low-income subsidy programs asset test and raise the income eligibility levels to 200 percent of the federal poverty level. Medicare Prescription Drugs. Drug Costs. Inflation Reduction Act (Public Law No: 117-169): Proposal to allow Medicare to negotiate prices with drug makers, cap prices at inflation in Part B and D, cap beneficiary out-of-pocket costs in Part D, eliminate cost-sharing for vaccines, eliminate cost-sharing in the catastrophic phase of Part D, and raise the income threshold for the low-income subsidy. Medicare Prescription Drugs. Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 (H.R. 3093): Proposes to require companies that receive federal funding for research (or a license of the rights to a patent or regulatory test data) for a biomedical product or service to agree to set reasonable prices for the resulting biomedical product or service and authorize to determine a reasonable price based on a formula that ensures the U.S. price for the product or service is not more than the median price for the product or service in Canada and six other reference countries with, based on specified criteria, large economies and high incomes. Medicare Prescription Drugs. Supported an administrative proposal encouraging the Secretaries of the Departments of Health and Human Services (HHS) and Commerce to exercise march in rights that would aim to better control the pricing of prescription drugs. Medicare Prescription Drugs. Supported HHS promulgating robust negotiation rules and processes that aim to curtail the cost of certain prescription drugs, as authorized by the Inflation Reduction Act. Medicare Low-Income Subsidy (LIS) Program. Supported increased funding for LIS outreach and enrollment, so that low-income beneficiaries can more readily access needed medications at prices they can afford. Medicare Reform. Assuring Medicares Promise Act (H.R. 34) and Medicare and Social Security Fair Share Act (S. 1174 and H.R 4535): Proposals to close the loophole for wealthy individuals who bypass paying net investment income tax (NIIT) and directing the revenue to the Hospital Insurance Fund, which pays for Medicare Part A that covers inpatient care in hospitals, and to the Social Security Trust Funds. Medicare Dental Coverage. Medicare Dental Benefit Act (S. 2012 and H.R. 4146): Proposal to add a dental benefit to Medicare. Medicare Hearing Coverage. The Medicare Hearing Aid Coverage Act of 2021 (H.R. 244): Proposal to expand Medicare coverage to include hearing aids and services for seniors under Part B of the Medicare program. Medicare call center (No bill): Proposal to address the poor working conditions of the call center workers employed by Maximus, a federal contractor with the Department of Health and Humans Services/Center for Medicare and Medicaid Services) HHS/CMS. Public Health emergency (No bill): Proposals to ensure the transition out of the public health emergency doesnt create enrollment or coverage gaps for Medicare eligible individuals. Medicare Advantage. (No bill): Proposals to create transparency around Medicare Advantage plans use of prior authorization and supplemental benefits that are not offered under traditional Medicare. Medicare Privatization (No bill): Proposals to create reimbursement policies in traditional Medicare that mimic those used by private health insurance plans. Medicaid Home And Community-Based Services. Inflation Reduction Act (Public Law No: 117-169): Proposals to expand Medicaid home and community-based services and the Medicare savings programs. Medicaid Home And Community-Based Services. HCBS Access Act (H.R. 1493 and S. 762). Proposals to make home and community-based services (HCBS) a mandatory benefit within Medicaid, and to ensure eligible older adults and people with disabilities have the option to choose between home care and institutional care. Medicare and Medicaid Nursing Homes. Nursing Home Disclosure Act (H.R. 177). Proposal to direct HHS to establish a national registry of medical directors. Medicare and Medicaid Nursing Home Ownership. (No bill) Supporting the strengthening of proposed HHS regulations for comprehensive ownership disclosure in the nursing home sector, and for national safe staffing standards. Medicare and Medicaid Nursing Home Staffing. Support for CMS to promulgate improved final regulations for establishing national staffing standards in nursing homes that would safeguard the health and safety of all elderly and disabled residents. Medicaid Long-Term Services and Supports (LTSS). (No bill): To request that CMS collect standardized LTSS expenditure data annually from every state and across all LTSS programs and for disaggregation of expenditure data by the delivery system and demographic characteristics in order to identify disparities in access and use of LTSS and help states and CMS deploy targeted strategies to meet the needs of older adults and people with disabilities.

Medicare Dental Benefit Act (H.R. 4146, S. 2012), Medicare Dental, Vision and Hearing Benefit Act (H.R. 33), Medicare Heart Aid Act (H.R. 244), Beneficiary Enrollment Notification and Eligibility Act 2.0 (S. 1687), Preserve Access to Affordable Generics and Biosimilars Act (S. 142).

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Sustaining Outpatient Services Act (H.R. 955) Regulations from the Executive in Need of Scrutiny (REINS) Act of 2023 (HR 277/S 184) Analyzing the Duration of Remote Patient Monitoring Services Act of 2023 (no bill number) Increasing Access to Quality Cardiac Rehabilitative Care Act (HR 2583) Black Maternal Health Momnibus Act (S. 1606/HR 3305) Medicare Dental Benefit Act (HR 4146/S. 2012) Accelerating Kids Access to Care Act (not yet introduced) Amputation Reduction and Compassion Act (H.R. 4261) CONNECT for Health Act (no bill number) Federal approval of certain state Medicaid 1115 innovation waivers improving patient access to care and equitable access to care. Coverage of self-measured blood pressure devices in Medicare. Coverage of cardiac rehabilitation for patients with HFpEF in Medicare. Policy relating to payment rules for hospital inpatient and inpatient rehabilitation facilities for FY 24. Medicaid FFS access and managed care policy rulemaking. CMS coverage of telehealth and remote patient monitoring post-public health emergency.

Client expense: $170,000 · Firm income: Not reported

Medicare Observation Stays. (No bill): Proposals to count time spent in observation status toward the three-day prior inpatient stay required under Medicare for coverage of a subsequent stay in a skilled nursing facility. Medicare Drug Prices (No bill): Proposal to have the Biden Administration lower the price of the prostate cancer drug Xtandi through executive action by using so-called march-in rights under the Bayh-Dole Act; to amend the Federal Food, Drug, and Cosmetic Act to grant eligible researchers access to drugs or biologic products for research purposes at a price no higher than the cost to the manufacturer; to block so-called Dispense-As-Written campaigns where drug manufacturers incentivize health care providers to specify a brand drug on a prescription to block generic substitution at the pharmacy. These campaigns increase drug spending by encouraging overuse of brand drugs when cheaper, equally effective generic alternative is available; and to reduce the period after Food and Drug Administration approval where a brand manufacturer could exclusively market their drug in the United States from 12 years to five years. This reduced exclusivity period would hasten the introduction of lower cost biosimilars to the market, helping bring down cost for consumers. Medicare Drug Costs. Pharmaceutical Research Transparency Act of 2023 (S. 1476 and H.R. 3160): Proposal to amend the Public Health Service Act and the Security Exchange Act to require pharmaceutical manufacturers to report their costs related to clinical trials and research and development. Medicare Drug Savings. Seniors Securing Access to Vital and Essential Prescription Drugs Act (H.R. 2893): Proposals to discount the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost sharing subsidies under Part D of the Medicare program. (No bills): Proposals to eliminate the Medicare Part D low-income subsidy programs asset test and raise the income eligibility levels to 200 percent of the federal poverty level. Medicare Prescription Drugs. Drug Costs. Inflation Reduction Act (Public Law No: 117-169): Proposal to allow Medicare to negotiate prices with drug makers, cap prices at inflation in Part B and D, cap beneficiary out-of-pocket costs in Part D, eliminate cost-sharing for vaccines, eliminate cost-sharing in the catastrophic phase of Part D, and raise the income threshold for the low-income subsidy. Medicare Prescription Drugs. Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 (H.R. 3039): Proposes to require companies that receive federal funding for research (or a license of the rights to a patent or regulatory test data) for a biomedical product or service to agree to set reasonable prices for the resulting biomedical product or service and authorize to determine a reasonable price based on a formula that ensures the U.S. price for the product or service is not more than the median price for the product or service in Canada and six other reference countries with, based on specified criteria, large economies and high incomes. Medicare Reform. Assuring Medicares Promise Act (H.R. 34): Proposal to close the loophole for wealthy individuals to bypass paying net investment income tax (NIIT) and would direct the revenue to the Hospital Insurance Fund, which pays for Medicare Part A that covers inpatient care in hospitals. Medicare Dental Coverage. Medicare Dental Benefit Act (S. 2012): Proposal to add a dental benefit to Medicare. Medicare Hearing Coverage. The Medicare Hearing Aid Coverage Act of 2021 (H.R. 244): Proposal to expand Medicare coverage to include hearing aids and services for seniors under Part B of the Medicare program. Medicare call center (No bill): Proposal to address the poor working conditions of the call center workers employed by Maximus, a federal contractor with the Department of Health and Humans Services/Center for Medicare and Medicaid Services) HHS/CMS. Public Health emergency (No bill): Proposals to ensure the transition out of the public health emergency doesnt create enrollment or coverage gaps for Medicare eligible individuals. Medicare Advantage. (No bill): Proposals to create transparency around Medicare Advantage plans use of prior authorization and supplemental benefits that are not offered under traditional Medicare. Medicare Privatization (No bill): Proposals to create reimbursement policies in traditional Medicare that mimic those used by private health insurance plans. Medicaid Home And Community-Based Services. Inflation Reduction Act (Public Law No: 117-169): Proposals to expand Medicaid home and community-based services and the Medicare savings programs. Medicaid Home And Community-Based Services. HCBS Access Act (H.R. 1493 and S. 762). Proposals to make home and community-based services (HCBS) a mandatory benefit within Medicaid, and to ensure eligible older adults and people with disabilities have the option to choose between home care and institutional care. Medicare and Medicaid Nursing Homes. Nursing Home Disclosure Act (H.R. 177). Proposal to direct HHS to establish a national registry of medical directors. Medicare and Medicaid Nursing Home Ownership. (No bill) Supporting the strengthening of proposed HHS regulations for comprehensive ownership disclosure in the nursing home sector, and for national safe staffing standards. Medicaid Long-Term Services and Supports (LTSS). (No bill): To request that CMS collect standardized LTSS expenditure data annually from every state and across all LTSS programs and for disaggregation of expenditure data by the delivery system and demographic characteristics in order to identify disparities in access and use of LTSS and help states and CMS deploy targeted strategies to meet the needs of older adults and people with disabilities.